Bacteria count culture medium for limit test of microbe in medication of quinolone category, and application

A microbial limit, quinolone technology, applied in the field of microbial culture medium engineering, can solve the problems of polluting microorganisms, difficult to remove, invalid test results, etc.

Active Publication Date: 2007-12-26

NAT INST FOR THE CONTROL OF PHARMA & BIOLOGICAL PROD

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AI-Extracted Technical Summary

Problems solved by technology

The only way to solve this problem is to increase the amount of flushing, but there are many defects in relying on this single method. First, after the mechanical flushing reaches a certain level, the basic adsorption amount of the drug on the filter membrane and the flushing reach a balance. , making it difficult to completely remove it by ...

Method used

Utilize the chelation of metal ion can reduce this feature of the activity of quinolones, in the appropriate link of quinolones microbial li...

Abstract

This invention discloses a bacteria-counting culture medium for microbial limit test of quinolone drugs. The culture medium is composed of multivalent cationic metal salt and nutrient agar culture medium at a ratio of 0.001-0.05 mol/L. The culture medium can be used for microbial limit test of sterile orally taken or external use quinolone raw material, oral injection and external use preparations, and is effective and simple.

Application Domain

Microbiological testing/measurement

Technology Topic

DrugQuinolone +5

Examples

Experimental program(9)

Example Embodiment

[0023] Example 1

[0024] The bacterial count medium for microbial limit inspection of quinolones is: peptone 10.0g, beef extract powder 5.0g, sodium chloride 5.0g, agar 14.0g, manganese sulfate (MnSO 4 ·H 2 O) 4.2g, 1000ml of water, adjusted to pH 7.1.

[0025] Preparation process: Weigh (quantify) the ingredients according to the above formula in turn, add 900ml of water to dissolve, adjust the pH to 7.1 with 1mol/L NaOH solution, and then add water to 1000ml. The same below.

Example Embodiment

[0026] Example 2

[0027] The preparation process is the same as in Example 1. The difference is that the bacterial count medium for microbial limit test of quinolone drugs is: peptone 10.0g, beef extract powder 5.0g, sodium chloride 5.0g, agar 14.0g, manganese sulfate (MnSO 4 ·H 2 O) 0.845g, 1000ml of water, adjusted to pH 6.9.

Example Embodiment

[0028] Example 3

[0029] The preparation process is the same as in Example 1. The difference is that the bacterial count medium for microbial limit test of quinolone drugs is: peptone 10.0g, beef extract powder 5.0g, sodium chloride 5.0g, agar 14.0g, manganese sulfate (MnSO 4 ·H 2 O) 16.9g, 1000ml of water, adjusted to pH 7.2.

PUM

Description & Claims & Application Information

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